Clinical trialPhase 3Withdrawn
Trial of Carbon Ion Versus Photon Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer
CIPHER: A Prospective, Multi-Center Randomized Phase 3 Trial of Carbon Ion Versus Conventional Radiation Therapy for Locally Advanced, Unresectable Pancreatic Cancer
- Outcome
- Stopped earlyDue to COVID and other recruitment issues the trial could not be initiated. (Enrollment)
- Phase
- Phase 3
- Status
- Withdrawn
- Study type
- Interventional
- Start
- 29 May 2019
- Expected end
- 1 July 2023
- Enrollment
- 0 participants
- Sites
- 2
- Primary outcomes
- Over all Survival
- Sponsor
- Other
- Results posted
- No
- Last update
- 26 May 2021
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Brief summary public domain (ClinicalTrials.gov)
To determine if carbon ion radiotherapy improves overall survival versus photon therapy in patients with locally advanced, unresectable pancreatic cancer
Detailed description public domain (ClinicalTrials.gov)
To compare the efficacy of carbon ion-based chemo radiotherapy with x-ray-based chemo radiotherapy for the treatment of locally advanced pancreatic adenocarcinoma by comparison of overall survival at 2 years following treatment. Patient has 2 in 3 chance of receiving Arm A and 1 in 3 chance of receiving Arm B. Arm A (chemoradiation takes place in Japan): CIRT in 12 fractions/treatments plus concurrent gemcitabine, followed by 4 cycles of gemcitabine + nab-Paclitaxel, or until progression or intolerance of therapy Arm B: IMRT in 28 fractions plus concurrent gemcitabine or capecitabine, followed by 4 cycles of gemcitabine + nab-Paclitaxel, or until progression or intolerance of therapy Per investigator discretion, patients may receive either: 1. Definitive treatment : 2. Neoadjuvant treatment: Adjuvant chemotherapy 4 cycles of gemcitabine/nab-paclitaxel or FOLFIRNOX, Gemcitabine alone if these regimens are unavailable