A Phase 2 interventional study of cis Platinum/Carboplatin, Pemetrexed Disodium and Undergo surgery in Chemotherapy, Adjuvant, Lung Adenocarcinoma, Stage I and Treatment, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Recruiting at 1 site in China. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-12-19.
Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Phase 2, Interventional, and Treatment
Among 15 studies testing cisplatin in Adenocarcinoma of Lung — 2 open to participants now, 3 under way, 1 of them phase 3. Cisplatin · Adenocarcinoma of Lung.
Among the 15 studies testing cisplatin in Adenocarcinoma of Lung, this one has the largest planned enrollment of the 13 interventional ones, is the only one that started in 2017, is one of 12 in phase 2, and was the 15th registered.
418 studies on the registry are indexed under Adenocarcinoma of Lung; 79 are open to participants now.
This study's planned enrollment of 460 is above the median of 60 across 293 interventional studies indexed under Adenocarcinoma of Lung.
Browse Adenocarcinoma of Lung studies →2 of the 15 studies testing cisplatin in Adenocarcinoma of Lung are open now, in 1 country. Each count lists the studies.
Cisplatin: first FDA approval 1978 (PLATINOL-AQ). What it is approved for, and how studies give it, is on its page →
Of the 58 Adenocarcinoma of Lung studies recruiting now, 36 (62%) set no upper age limit and 10 (17%) stop at 75 or younger; 4 take children under 18; 4 take healthy volunteers.
This study: 19 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 1 started in 2017.
Median enrollment 116 across the 13 interventional studies. Of the 10 that completed or were terminated, 2 (20%) have results posted.
None of the 15 has an industry lead sponsor. The 10 most frequent:
Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 160 studies on the registry; 95 are open to participants now.
10 studies in Adenocarcinoma of Lung by Shanghai Pulmonary Hospital, Shanghai, China: 7 open now, 7 under way, 1 of them phase 3. Of 1 finished, 0 (0%) have results posted.
Among the 10 studies in Adenocarcinoma of Lung by Shanghai Pulmonary Hospital, Shanghai, China, this one is the only one that started in 2017, is one of 4 in phase 2, and was the 1st registered.
Shanghai Pulmonary Hospital, Shanghai, China’s Adenocarcinoma of Lung studies by the year they started, since 2017.
None of the studies under way reaches primary completion within a year.
Among the 15 studies testing cisplatin in Adenocarcinoma of Lung, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Shanghai Pulmonary Hospital, Shanghai, China’s 10 in Adenocarcinoma of Lung:
Nothing recorded among them since 2026-09-25.
Randomized phase II trial aims to compare surgery with or without adjuvant chemotherapy in treating patients who are pathologically diagnosed as stage I lung adenocarcinoma with micropapillary component no less than 20%.
The presence of micropapillary component in adenocarcinoma is a predictor of poor prognosis, and has been reported to be to be chemosensitive to platinum-based chemotherapy. Seeking a more appropriate treatment for these patients, we perform this randomized phase II clinical trial. About 460 stage I lung adenocarcinoma patients with micropapillary component ≥ 20% will be included and divided into two group. Patients in the control group will only undergo complete R0 resection of the lesion, no further therapy will be used. While patients in the experimental group are going to receive platinum-based chemotherapy (comprising cisplatin and pemetrexed disodium)about 1 month after therapeutic surgery. Treatment continues every 3 weeks for 4 courses. Clinic and telephone follow up will be conducted for survival data monitoring.
DFS(disease free survival rate) and OS(overall survival rate) curves will be calculated using the Kaplan-Meier, life-table method. Comparison of the survival curve for the two groups will be performed using the log-rank test.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Undergo surgery, followed by observation. Patients receive no further therapy
Procedure: Undergo surgery
Undergo surgery, followed by chemotherapy (cis Platinum/Carboplatin, Pemetrexed Disodium). Patients receive chemotherapy comprising cisplatin 75mg/m2 or Carboplatin AUC=5mg/ml/min, and pemetrexed 500mg/m2 in day 1. Treatment continues every 3 weeks for 4 courses.
Drug: cis Platinum/Carboplatin, Pemetrexed Disodium · Procedure: Undergo surgery
Drug pages: Cisplatin · Carboplatin · Pemetrexed
Intravenous inject Pemetrexed Disodium for Injection over 10 minutes, waiting for at least 30 minutes, then followed by cis Platinum/ Carboplatin over 2 hours
Also known as: Pemetrexed Disodium for Injection, ALIMTA, Cisplatin, Paraplatin
Therapeutic conventional surgery, R0 resection
Disease-Free-Survival-Rate
the percentage of people in the trial who are alive and cancer free after a specified number of years
Time frame: up to 60 months
Overall-Survival-Rate
the percentage of people in the trial who alive, with or without signs of cancer
Time frame: up to 60 months
Disease-Free-Survival-Time
From date of diagnosis until the date of first documented progression or date of cancer related death , whichever came first
Time frame: up to 60 months
Overall-Survival-Time
Time from randomization until death from any cause
Time frame: up to 60 months
Started Sep 2017 (actual). Primary completion is estimated for Sep 2019, 24 months after the start.
Of 45 non-industry phase 2 interventional studies under Adenocarcinoma of Lung, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 73. This study's planned 24 months is below that.
Counting every sponsor, half of 53 studies reached it within 53 months; a quarter within 33 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Cisplatin · Carboplatin · Pemetrexed
Shanghai Pulmonary Hospital, Shanghai, China →