A Phase 2 interventional study of rhTPO and irinotecan in Recurrent Colorectal Carcinoma and Thrombopenia, sponsored by Fudan University. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-01-30.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
This randomized controlled clinical phase II study was designed to compare the effect of rhTPO with rhIL-11 in improving thrombocytopenia in patients with recurrent colorectal cancer who underwent radiotherapy and with thrombocytopenia.
Most patients with recurrent CRC have undergone a six-month postoperative adjuvant chemotherapy with oxaliplatin plus fluorouracil. Although the main dose-limiting side effect of oxaliplatin is neurotoxicity, with the widespread use of this drug, there are more and more reports that oxaliplatin is discontinued because of thrombocytopenia, which increases the risk of bleeding, rate of blood transfusion needs and length of stay. On the other hand, patients undergoing pelvic radiotherapy may also experience significant bone marrow suppression because flat bones such as the tibia may be exposed to high doses radiation. Low platelet counts is an urgent problem to be solved in order to give adequate quantitative radiotherapy. This randomized controlled clinical phase II study was designed to compare the effect of rhTPO with rhIL-11 in improving thrombocytopenia in patients with recurrent colorectal cancer who underwent radiotherapy and with thrombocytopenia, thus providing more evidence in clinical practice.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 50 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
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Exclusion Criteria:
rhTPO: 300 u/kg, subcutaneous injection, per day. (stopped as soon as the platelet count rises to normal) Concurrent Chemoradiotherapy: Radiation: judged according to the tumor site and radiotherapy purpose. Irinotecan: 80 mg/m2 (UGT1A1\*28 6/6) or 65 mg/m2 (UGT1A1\*28 6/7) Raltitrexed: 3 mg/m2 q3w
Drug: rhTPO · Drug: irinotecan · Drug: Raltitrexed · Radiation: radiotherapy
rhIL-11: 50 ug/kg, subcutaneous injection, per day. (stopped as soon as the platelet count rises to normal) Concurrent Chemoradiotherapy: Radiation: judged according to the tumor site and radiotherapy purpose. Irinotecan: 80 mg/m2 (UGT1A1\*28 6/6) or 65 mg/m2 (UGT1A1\*28 6/7) Raltitrexed: 3 mg/m2 q3w
Drug: irinotecan · Drug: Raltitrexed · Radiation: radiotherapy · Drug: rhIL-11
rhTPO 300u/kg, subcutaneous injection, qd
80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7)
3mg/m2 q3w
in the use of intensity-modulated radiotherapy (IMRT) technology, the dose is judged according to the tumor site and radiotherapy purpose.
rhIL-11 50ug/kg, subcutaneous injection, qd
the rate of recovery of platelet accounts
Time frame: From date of chemoradiation until the date of first documented recovery, assessed up to 6 months
the duration after returning to normal
Time frame: From date of first documented recovery until the date of first documented decrease of platelet accounts, assessed up to 6 months
cycles of concurrent chemotherapy patients received during radiotherapy
Time frame: through chemoradiation, an average of 5 weeks
change of participant quality of life during treatment as assessed by EORTC-quality of life questionnaire-C30
Time frame: at the beginning and the end of chemoradiation.
change of participant quality of life during treatment as assessed by EuroQol-5 dimensional (EQ-5D) questionnaire
Time frame: at the beginning and the end of chemoradiation.
the rate of pathological complete response.
pathological complete response (pCR) was defined no viable cancer cell under the examination of surgical resection specimen.
Time frame: Surgery scheduled 6-8 weeks after the end of chemoradiation
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Fudan University