ClinicalTrials.gg
Status unknownNCT03381352Updated Jan 30, 2018

Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer

A Phase 2 interventional study of Chemo-radiotherapy with IMRT technique and Capecitabine in Anal Cancer, sponsored by Chinese Academy of Medical Sciences. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-01-30.

Sponsored by Chinese Academy of Medical Sciences · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Dec 2015, registered Dec 2017).
Phase
Phase 2
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy and adverse events of intensity modulated radiation therapy (IMRT) concurrent with chemotherapy for anal squamous carcinoma. All enrolled anal squamous carcinoma patients are intented to receive IMRT concurrent with Capecitabine + mitomycin ± cetuximab targeted therapy.

02

Conditions studied

  • Anal Cancer

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Keywords

  • Radiotherapy
  • Anal cancer
  • IMRT
03

In context

Anus Neoplasms

297 studies on the registry are indexed under Anus Neoplasms; 74 are open to participants now.

This study's planned enrollment of 27 is below the median of 66 across 211 interventional studies indexed under Anus Neoplasms.

Browse Anus Neoplasms studies →

Lead sponsor

Chinese Academy of Medical Sciences is the lead sponsor of 237 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • CT/MRI diagnosed stage cT1-4N0-3;
  • confirmed anal squamous carcinoma;
  • >= 70
  • Adequate organ function;
  • No previous radiotherapy or chemotherapy;
  • No surgery.

Exclusion criteria

Exclusion Criteria:

  • Previous malignant cancer history;
  • Allegic to 5-fu or MMC
Terms in these criteria, in plain language(2)

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.

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.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (estimated)

Study arms

  • Experimental
    Chemo-radiotherapy with IMRT technique

    Radiotherapy with IMRT technique concurrent with Capecitabine and MMC chemotherapy

    Radiation: Chemo-radiotherapy with IMRT technique · Drug: Capecitabine · Drug: Mitomycin C

Interventions

  • RadiationChemo-radiotherapy with IMRT technique

    IMRT radiation technique; 50.4-54Gy/25F

  • Capecitabine 825mg/m2 PO BID

  • Mitomycin C 10mg/m2 D1,29 iv

06

What researchers measure

Primary outcomes

  1. Response rate

    To evaluate response rate of IMRT with chemotherapy

    Time frame: 8 weeks after IMRT

Secondary outcomes

  1. Adverse events

    To assess the adverse events of IMRT with chemotherapy

    Time frame: from start of IMRT to 8 weeks after IMRT

07

Study locations

1 of 1 sites recruiting
  • Chinese academy of medical sciences
    Beijing, Beijing 100021, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03381352
Responsible party
LI Ning (Principal Investigator, Chinese Academy of Medical Sciences) — Principal investigator
First posted
Dec 22, 2017
Start date
Dec 2, 2015
Primary completion
Dec 31, 2018 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Jan 30, 2018

Study contacts

Ning Li, MD
Contact
lee_ak@163.com
0086-13810381399

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Capecitabine · Mitomycin

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