Comparing chemotherapy alone versus chemotherapy with high dose radiation for unresectable cholangiocarcinoma
Phase III Randomized Trial of High Dose Chemoradiation and Systemic Chemotherapy vs Systemic Chemotherapy Alone in Patients With Unresectable Nonmetastatic Cholangiocarcinoma
PHASE3 · Tata Memorial Hospital · NCT02773485
This study is testing if adding high dose radiation to chemotherapy can help people with unresectable cholangiocarcinoma live longer compared to chemotherapy alone.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 155 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tata Memorial Hospital (other gov) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Navi Mumbai, Maharashtra) |
| Trial ID | NCT02773485 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of high dose radiation combined with systemic chemotherapy in improving overall survival for patients with unresectable nonmetastatic cholangiocarcinoma. Participants will be randomly assigned to receive either chemotherapy alone or chemotherapy plus high dose radiation. The aim is to determine if the addition of radiation can enhance survival rates compared to chemotherapy alone, given the current limitations of treatment options. The study seeks to provide level I evidence for the use of concurrent chemoradiation in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a diagnosis of unresectable nonmetastatic cholangiocarcinoma and a performance status of 0-2.
Not a fit: Patients with multicentric intrahepatic cholangiocarcinoma or those with distant metastasis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with unresectable cholangiocarcinoma.
How similar studies have performed: While concurrent chemoradiation has been used for decades, this study aims to provide new evidence on its effectiveness specifically for unresectable cholangiocarcinoma, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * Performance Status 0-2 * Tissue diagnosis of adenocarcinoma of the biliary tract. Wherever tissue diagnosis is not feasible in spite of repeated attempts a multidisciplinary consensus on clinicoradiological diagnosis of cholangiocarcinoma (CA 19-9= 100mg/ml with a radiological evidence of malignant stricture) should be made and patients consent should be available for treatment without tissue diagnosis. * Unresectable disease as determined by hepatobiliary surgical team. * No evidence of peritoneal or distant metastasis. * No radiological evidence of paraaortic nodal disease. * Child A or Child B (score 7) * Ability to tolerate radical treatment. Exclusion Criteria: * Multicentric intrahepatic cholangiocarcinoma (however adjacent satellite lesions are permitted) * Inability to deliver safe radiation due to high tumor/ liver ratio. * Active cholangitis. * Expected Survival\<6 months. * Unresolved biliary tract obstruction. * Inability in deliver systemic chemotherapy (persistent bilirubin\>3)
Where this trial is running
Navi Mumbai, Maharashtra
- Advanced Centre of Treatment Research and Education In Cancer,Tata Memorial Centre — Navi Mumbai, Maharashtra, India (RECRUITING)
Study contacts
- Principal investigator: Supriya Chopra, MD — ACTREC,Tata Memorial Centre
- Study coordinator: Supriya Chopra, MD
- Email: supriyasastri@gmail.com
- Phone: 09930958309
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cholangiocarcinoma