Table 2.
Review of current trials evaluating carbon ion radiation therapy (CIRT).
| Trial | Location | Population | Arms |
|---|---|---|---|
| CENTRAL NERVOUS SYSTEM | |||
| MARCIE trial (NCT01166321) | HIT | Simpson grade 4–5 meningioma | A: 48–52 Gy photons with 18 GyE/6 fraction CI boost |
| PINOCCHIO trial (NCT01795300) | HIT | Skull base meningioma | A: Conventionally fractionated radiation (57.6 Gy/32 fractions) B: Hypofractionated photon (45 Gy/15 fractions) C: Proton (45 GyE/15 fractions) D: CIRT (45 GyE/15 fractions) |
| CLEOPATRA (NCT01165671) |
HIT | Primary glioblastoma | A: 48–52 Gy photons with 18 GyE/6 fraction CI boost B: 48–52 Gy photons with 10 GyE/5 fraction proton boost |
| CINDERELLA (NCT01166308) |
HIT | Recurrent gliomas | A: Fractionated stereotactic radiotherapy (up to 36 Gy/18 fractions) B: CIRT (dose escalating 30–48 GyE/10–16 fractions) |
| SKULL BASE | |||
| CSP12C (NCT01182753) |
HIT | Skull base chondrosarcoma | A: CIRT 60 GyE B: Proton 70 GyE |
| HIT-1 (NCT01182779) |
HIT | Skull base chordoma | A: CIRT 63 GyE B: Proton 72 GyE |
| HEAD AND NECK | |||
| COSMIC (NCT01154270) |
HIT | Salivary gland tumors with inoperable, N+, residual disease | A: 50 Gy IMRT followed by CI boost (24 GyE/8 fractions) |
| Trial evaluating particle therapy with or without apatinib for H&N adenoid cystic carcinoma (NCT02942693) | SPHIC | Adenoid cystic carcinoma | A: Proton therapy (56 GyE/28 fractions) with CI boost (15 GyE/5 fractions) A: Proton therapy (56 GyE/28 fractions) with CI boost (15 GyE/5 fractions) with apatinib |
| ACCEPT (NCT01192087) |
HIT | Adenoid cystic carcinoma | A: Combination IMRT with CI boost and erbitux |
| IMRT-HIT-SNT (NCT01220752) | HIT | Sinonasal tumors | A: IMRT in 2 Gy per fraction and CI boost (24 GyE/8 fractions) |
| GASTROINTESTINAL | |||
| Trial evaluating carbon ion radiation therapy for locally recurrent nasopharyngeal carcinoma (NCT02795195) | SPHIC | Locally recurrent nasopharyngeal carcinomas | A: Dose escalation (54–63 GyE in 3 GyE daily fractions) |
| PROMETHEUS-01 (NCT01167374) |
HIT | HCC | A: Dose escalation (40–56 GyE/4 fractions) |
| Phase II trial of carbon-ion radiotherapy combined with GM-CSF for the treatment of hepatocellular carcinoma (NCT02946138) | SPHIC | HCC | A: Hypofractionated carbon ion radiation (40 GyE/5 fractions) with GM-CSF |
| Proton and carbon ion radiotherapy for locally advanced pancreatic cancer (NCT03949933) | SPHIC | Locally advanced pancreatic cancer | A: Proton therapy to 50.4 GyE/28 fractions with a CI boost (12–18 GyE in 3 GyE per fraction) |
| PIOPPO (NCT03822936) |
CNAO | Resectable or borderline resectable pancreatic adenocarcinoma | A: Neoadjuvant FOLFIRONX followed by 38.4 GyE/8 fractions CIRT. Resection and adjuvant gemcitabine |
| CIPHER (NCT03536182) | UT Southwestern (treatment in Japan) | Unresectable pancreatic cancer | A: CIRT in 12 fractions with concurrent gemcitabine and adjuvant gemcitabine and nab-paclitaxel B: IMRT in 28 fractions with concurrent gemcitabine and adjuvant gemcitabine and nab-paclitaxel |
| PANDORA-1 (NCT01528683) |
HIT | Recurrent and inoperable rectal cancer | A: Dose escalation (36–54 GyE in 3 GyE fractions) |
| GENITOURINARY | |||
| Carbon ions boost followed by pelvic photon radiotherapy for high risk prostate cancer (NCT02672449) | CNAO | High risk prostate cancer | A: CI boost followed by pelvic IMRT to 45 Gy |
| Carbon ion radiotherapy in treating patients undergoing systemic therapy for oligo-metastatic prostate cancer (NCT02935023) | SPHIC | Oligo-metastatic prostate cancer | A: CIRT to the prostate (59.2 GyE/16 fractions) with hormone therapy or chemotherapy |
| SARCOMA | |||
| ISAC (NCT01811394) |
HIT | Sarcococcygeal chordoma | A: Proton irradiation (4 GyE × 16 fractions) B: CIRT (4 GyE × 16 fractions) |
| SARCO (NCT02986516) |
Italian Sarcoma Group | Sacral chordoma | A: Surgery with or without radiation (including CIRT) B: Definitive radiation |
CI, carbon ion; CNAO, National Center of Oncological Hadronotherapy, Italy; HCC, hepatocellular carcinoma; HIT, Heidelberg Ion Therapy Center; IMRT, intensity modulated radiation therapy; N+, node positive; SPHIC, Shanghai Proton and Heavy Ion Center; UT, University of Texas.